Ektachem Clinical Chem. Slides

• • Terminated Z-1226-2014 FDA Class II ·initiated 9 Jan 2014

  An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658.

• • Terminated Z-0324-2014 FDA Class II ·initiated 12 Jun 2013

  Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

510(k) Number

K840880 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Kodak Surecell Hcg Urine Test, Modification

  Class II

  FDA 510(k) K936287 Active Cleared 8 Apr 1994

• Kodak Ektaspeed Dental X-Ray Film

  Class I

  FDA 510(k) K800901 Active Cleared 20 May 1980

• Kodak X-Omat 3000 Ra Processor

  Class II

  FDA 510(k) K951396 Active Cleared 15 May 1995

• Kodak X-Omat M43A, M43, & Clinic 1 Processors

  Class II

  FDA 510(k) K934350 Active Cleared 21 Mar 1994

• Amerlite Prolactin-30 Assay

  Class I

  FDA 510(k) K922170 Active Cleared 2 Sep 1992

• Trophypan C with Orthoimaging/Omsimaging Accessory

  Class II

  FDA 510(k) K040556 Active Cleared 7 Apr 2004

See all devices from Eastman Kodak Company →